We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Apply to become or identify an approved manufacturer authorised to carry out conformity assessment.
How to ensure the products you make or import comply with the law and are safe for consumers to use.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
If the UKCA marking applies to products you manufacture or supply, you will have specific obligations and responsibilities for compliance, depending on your role.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Forms to make a variation to a manufacturer's licence.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).